Kornimate/medical-research-clean huggingface dataset:
nursing and pharmacy time for delivering xeloda® versus 5-fluoruracil regimens

Conditions: Colorectal Cancer

Summary: this is a prospective time-and-motion study to document and compare the time used in preparation, dispensing and administration for capecitabine/oxaliplatin (xelox) versus iv 5-fu/leucovorin/oxaliplatin (folfox4) regimens in colorectal cancer (crc) patients.

colorectal cancer (crc) is the second most common cause of cancer-related death in hong kong. the traditional chemotherapy for crc remains on intravenous (iv) fluorouracil (5-fu) based regimens with the response rates of 10-20% and a median survival of approximately one year. recent years, oral chemotherapy has a more practical and economic advantages over iv regimen. it is understandable that patients prefer oral regimens as long as the clinical efficacy is maintained. oral treatment strategy preserves quality of life for crc patients. in a previous cost-minimization study conducted in hong kong, it was demonstrated that capecitabine was more cost-effective than 5-fu plus oxaliplatin assuming they had equal clinical efficacy. not only is capecitabine more cost-effective, it may also have additional cost saving in the nursing and pharmacy time . it is because a significant amount of time can be saved in both nursing and pharmacy for the preparation and administration of iv chemotherapy. in the uk, it was demonstrated that capecitabine required less pharmacy and administration time per cycle than 5-fu based iv chemotherapy. however, there is a lack of local data to demonstrate the impact of pharmacy and nursing care utilizing capecitabine comparing to traditional iv chemotherapy in crc patients of hong kong.

Eligibility criteria:
inclusion criteria: * age 18 or above * diagnosed with crc and prescribed with either xelox for folfox4 chemotherapy treatment exclusion criteria: * patients less than 18 years of age * persons related unequally to investigators * patients who are mentally/cognitively disabled * patients who refuse to give consent to participate

Keywords: time-and-motion neoplasm colorectal cancer
morbidity, long-term side effects and quality of life in germ-cell tumor long survivors treated with high-dose chemotherapy and autologous stem cell transplant

Conditions: Germ Cell Tumor

Summary: intensified chemotherapy is an effective treatment in 30-70% of patients with refractory germ cell tumor. since most cases are diagnosed before the age of 40, survivors can expect to live another 30 to 50 years after being successfully treated. long-term side effects and physical and emotional consequences can therefore have a significant impact on daily life. to date, no data of this type is available in france. this study will help clinicians better understand the long-term consequences for relapsed patients receiving high-dose chemotherapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years at diagnosis * treated between 1990 and 2015 * histologically confirmed diagnosis of germ cell tumor (or high level serum tumor marker-based) and: treated for relapse with high-dose of chemotherapy (hdct) with autologous transplant at gustave roussy and relapse-free. or treated by orchiectomy only and no evidence of relapse after a minimum of 3 years. or good or intermediate prognosis metastatic disease according to the igcccg, treated by first line cisplatin-based chemotherapy at gustave roussy (and surgery of residual masses if needed), with no evidence of relapse. * ability to comply with the protocol procedures * patient affiliated to a social security system or beneficiary of the same. 6-who have signed a written informed consent form prior to any study specific procedure. exclusion criteria: * diagnosis of second malignancy * any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results. * patient under guardianship or deprived of his/her liberty by a judicial or administrative decision, or incapable of giving his/her consent.
caremm-2306: advanced immunotherapy vs. classical immunotherapy

Conditions: Lymphoma

Summary: the goal of this retrospective study is to compare between the case cohort and control cohort. the case cohort consists of lymphoma patients treated with novel immunotherapy regimen including chimeric antigen receptor t cell therapy, bispecfic antibody, and/or antibody-drug conjugate. the control cohort consists of lymphoma patients who received conventional chemotherapy as standard-of-care the main question\[s\] it aims to answer are: * survival times * response outcomes

1. primary endpoints comparison of survival time by treatment between two groups 2. secondary endpoints 2.1 comparison of progression-free survival between two groups 2.2 comparison of response rates between two groups 2.3 comparison of input medical costs between two groups. 2. study subjects: patients treated for lymphoma at yeouido st. mary's hospital and seoul st. mary's hospital (both are located on seoul, korea) between may 2009 and june 2023. 3. selection criteria: 3.1 patients diagnosed with malignant lymphoma at catholic yeouido st. mary's hospital and seoul st. mary's hospital between may 2009 and june 2023. 3.2 age 19 or older. 3.3 patients who treated with salvage chemotherapy for the relapsed/refractory lymphoma. 4. exclusion criteria: 4.1 patients suffering from acute leukemia. 4.2 patients additionally diagnosed with solid cancer (colon cancer, lung cancer, stomach cancer, etc.) during treatment.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with malignant lymphoma at catholic yeouido st. mary's hospital and seoul st. mary's hospital between may 2009 and june 2023. 2. age 19 or older. 3. anti-cancer salvage chemotherpay for the treatment of relapsed/refractory lymphoma. exclusion criteria: 1. patients suffering from acute leukemia. 2. patients additionally diagnosed with solid cancer (colon cancer, lung cancer, stomach cancer, etc.) during treatment.
p16 and ki-67 stainings and natural killer (nk) cells in cin-ii management

Conditions: Cervical Cancer

Summary: the objective of this study is to evaluate the outcome of cervical intraepithelial neoplasia grade 2 (cin-ii) patients followed up without treatment for 24 months according to p16 and ki-67 immunohistochemical staining and to the expression of nk cell receptors.

cervical cancer and its precursor lesions, cervical intraepithelial neoplasia (cin), represents a significant public health problem,induced by persistent infection of human papillomavirus (hpv). it is known that a significant percentage of cin regresses spontaneously and only a minority of these lesions progress to cervical cancer. cin-ii is an intermediate state that can regress to cin-i or less, or progress to cin-iii spontaneously. the rate of spontaneous regression and progression in follow-up studies are around 40-60% and 10-20%, respectively. overestimating cin-ii lesions may cause overtreatment by excisional treatment and increase the risk of subsequent obstetric complications. patients newly diagnosed with cin-ii colposcopy-directed biopsy who agreed to follow up at four months intervals for at least 12 months with cervical cytology and colposcopy, were prospectively recruited. p16, ki-67 and nk receptors expression were analyzed in all cin-ii biopsies. total regression, partial regression, persistence and progression rates of cin-ii were defined as a final outcome.

Eligibility criteria:
inclusion criteria: * preferred expectant management than immediate treatment * exocervical histological diagnosis of cin-ii * lesion completely visualized by colposcopy * entire squamocolumnar junction of the cervix was visible * showing no evidence of any immunodeficiency disease * no history of previous cervical treatment * could be followed-up every four months during one year * signed consent form exclusion criteria: * not coming to follow up appointments

Keywords: expectant management p16 immunohistochemistry regression progression cervical intraepithelial neoplasia
asian outcomes of primary breast augmentation

Conditions: Breast Augmentation

Summary: in 162 asian patients, primary breast augmentations were performed by a single surgeon during 5 years. the purpose of this study evaluates asian outcomes in primary breast augmentation using single antibiotic breast irrigation by a single surgeon's practice and examines the comparison of asian and western outcomes in primary breast augmentation.

a retrospective chart review was performed to examine a total of 162 patients received the same brand of implants for primary breast augmentation under sedative anesthesia (propofol infusion) in a single surgeon's practice. asian patients' demographics, preoperative and postoperative measurements, surgical technique (single antibiotic breast irrigation), implant type, size, texture, soft tissue coverage, implant placement, incision approach, complications, and incidence of reoperation were documented.

Eligibility criteria:
inclusion criteria: * primary case exclusion criteria: * secondary case * breast reduction

Keywords: capsular contracture reoperation breast augmentation
nationwide treatment survey of intracranial arteriovenous malformation in china

Conditions: Intracranial Arteriovenous Malformations

Summary: this register study will collect the treatment information of the intracranial arteriovenous malformation patients in china. we aim to understand the current treatment situation of the disease in china.

intracranial arteriovenous malformations are congenital lesions that consist of multiple arteries and veins, connecting as a fistula without intervening normal capillary bed. the treatment strategy including surgical removal, endovascular embolism and stereotaxic radiosurgery and comprehensive treatment. china is a united multi-ethnic nation of 56 ethnic groups, and has the largest population in the world. we have most extensive and valuable clinical resources of intracranial arteriovenous malformation in the world. but we know little about the current treatment situation of the disease in china. in order to realize the treatment situation of intracranial arteriovenous malformation in china, we designed a retrospective and prospective register study to collect the treatment and outcome information all over china.

Eligibility criteria:
inclusion criteria: * all the patients that diagnosed of intracranial avm by dsa/ct/mri * all patients gave written informed consent exclusion criteria: * patients refuse to attend the survey

Keywords: intracranial arteriovenous malformations surgical removal endovascular embolism stereotaxic radiosurgery outcomes
the added value of a third supervised training session to a standard 12-week rehabilitation program after breast cancer: pilot study

Conditions: Breast Cancer

Summary: breast cancer is the most common type of cancer diagnosed in women. a good rehabilitation program is essential for a good recovery after breast cancer, both physically and mentally. the aim of this study is to determine if there is an added value of a third supervised training session within a standard 12-week rehabilitation program to improve physical and mental functioning after breast cancer. the investigators also want to determine the added value of hydrotherapy as a third training session within a 12-week rehabilitation program compared to a third training session with ground exercises to improve physical and mental functioning after breast cancer.


Eligibility criteria:
inclusion criteria: * men and women after surgery for breast cancer (mastectomy/breast-conserving and/or axillary gland resection/sentinel biopsy) * possible (neo)adjuvant chemotherapy and radiotherapy have been completed * hormone and/or immunotherapy may still be ongoing exclusion criteria: * comorbidities that make hydrotherapy impossible, i.e. open wounds or allergy to chlorine * oncological unstable disease * terminal patients * severe physical disabilities * severe mental disabilities * pregnancy

Keywords: rehabilitation hydrotherapy
treatment of female genital erosive lichen planus(gelp) with hexaminolevulinate pdt

Conditions: Genital Lichen Planus

Summary: to compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus

to assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (hal)-pdt in gelp in women.

Eligibility criteria:
inclusion criteria: women with symptomatically genital elp, clinically verified by at least one doctor attended to the vulva clinic. untreated for elp for at least 4 weeks. written informed consent signed age 18 or above exclusion criteria: current pelvic inflammatory disease, genital malignancy, or gynecological infection. known or suspected porphyria known allergy to hexaminolevulinate or similar compounds (e.g. hexaminolevulinate or aminolevulinic acid) pregnancy and lactation participation in other clinical study either concurrently or within the last 30 days
the ability of pecan consumption to improve vascular function and reduce chronic disease risk in aging adults

Conditions: Aging

Summary: background: to date, there are no published studies on the effects of pecans on vascular function following a high-fat meal. purpose: to examine the impact of daily pecan consumption for a 4-week period on vascular health and other markers of cardiovascular disease risk in aging adults.

this will be a randomized, controlled trial in men and postmenopausal women (50-75y). subjects will be randomized into one of the two study groups: a control group (con) following their usual diet, or intervention group (pecan) following their usual diet but also consuming 68g/day of pecans as a snack. there will be 3 visits: a screening visit and a baseline and post-diet intervention visit (4-weeks). anthropometrics, questionnaires, a fasting blood sample, and fasting vascular measures will be collected at each visit. subjects will participate in a saturated fatty acid meal challenge in which additional blood, vascular measurements will be collected. hypothesis: daily pecan consumption will result in improved fasting blood lipids, vascular measures, antioxidant status, and appetite compared to the control group. additionally, also the pecan group will result in improved postprandial blood lipids and vascular measures compared to the control group.

Eligibility criteria:
inclusion criteria: * men and postmenopausal women (without menses for 1 yr and follicle stimulating hormone \> 30 iu/ml) between the ages of 50-75y * body mass indexes (bmi) between 18-34.9kg/m2 exclusion criteria: * nut consumption \>2 servings/week or tree nut butter consumption \>3 servings/week * pre-menopausal and menopausal women, hormone replacement therapy if less than 2 years * regularly exercise more than 3 h/week * weight gain or loss more than 5% of their body weight in the past 3 months * plans to begin a weight loss/exercise regimen during the trial * gastrointestinal surgeries, conditions or disorders * history of medical or surgical events that could affect swallowing * chronic or metabolic diseases * previous mi, stroke, or cancer * fasting blood glucose levels greater than 126 mg/dl * blood pressure greater than 180/120 mmhg * medication use affecting digestion and absorption, metabolism * lipid-lowering medications * medications for diabetes, depression, or add/adhd * regular use of medications known to affect endothelial function or blood vessel tone * blood pressure medication and steroid/hormone therapies * individuals on a medically prescribed or special diet * individuals with food allergies to foods specifically in the study * excessively use alcohol (greater than 3 drinks/d for men; greater than 2 drinks/d for women) * tobacco or nicotine use * individuals taking fish oil and omega-3 fatty acid supplements * significant head trauma or brain surgery * a score \>26 on the beck's depression inventory ii (bdi-ii) * a score \<24 on the mini-mental state examination (mmse) will be excluded.
understanding the effects of intervention on the brain in autism

Conditions: Autism Spectrum Disorder; Asperger Disorder; PDD-NOS; Autism

Summary: this study examines how the peers (laugeson \& frankel, 2010; laugeson, 2016) social-behavioral intervention affects social relationships and brain development and function in autistic preschoolers, adolescents, and young adults.


Eligibility criteria:
inclusion criteria: * verbal, speaking in full sentences * meets asd criteria * meets iq criteria \>70 exclusion criteria: * schizophrenia or bipolar disorder

Keywords: peers friendships brain
a multi-centric study to assess the efficacy of sigmart in subjects with recurrent angina after coronary revascularization

Conditions: Angina Pectoris

Summary: the multi-centric, open label, single arm and self controlled study is planned to assess the efficacy of orally administered sigmart in subjects with recurrent angina after coronary revascularization. the primary objective of this study is to demonstrate that orally administered sigmart can improve the major exercise tolerance test (ett) result in recurrent angina subjects.


Eligibility criteria:
inclusion criteria: * subjects should be 18\~70 years old, male or female * subjects should have a history of coronary revascularization at least 6 months ago * subjects should present with typical angina or similar to the chest pain before prior coronary revascularization for at least 1 month * subjects should be relieved from anginal attacks with short-acting ntg * subjects should have the ability to withhold medication which cannot be concomitant in this clinical study during the study * subjects should have an ability to give written informed consent exclusion criteria: * unstable angina * left main coronary artery disease * aortic stenosis * obstructive hypertrophic cardiomyopathy * subjects with hypertension (sbp\>170 mmhg or dbp\>100 mmhg) or hypotension (sbp\<90 mmhg or dbp\<60 mmhg) * postural hypotension (drop in systolic blood pressure \>20% after 2 minute standing), * congestive heart failure (nyha class iii - iv) * ejection fraction (ef)\<45% by echocardiography * peripheral arterial obstructive disease or other diseases limiting exercise testing * arrhythmias requiring active treatment * gastro-intestinal ulcer * liver dysfunction (defined as alt or bilirubin\>1.5×upper limit of normal value) * significant renal impairment, such as serum creatinine greater than 1.5 folds the upper limit of normal as determined by local clinical laboratory * glaucoma * concomitant medication such as trimetazidine, sulphonylurea, pde-5 inhibitor such as sildenafil, chinese traditional medicine for treatment of angina pectoris * known intolerance to nitrates * known allergic to nicotinic acid * pregnant or lactating women * any other contraindications mentioned in the spc * participation in another clinical study within the last 3 months * legal incapacity or limited legal capacity * any other subjects assessed by the investigator as being unsuitable for the present study

Keywords: angina pectoris, coronary disease
assessment of arvo web-based software for evaluating attention-deficit/hyperactive disorder (adhd) symptoms in children

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: clinical investigation is aimed to assess the performance and safety of web-based arvo 2.0, for evaluating possible attention-deficit/hyperactive disorder (adhd) symptoms in children. possible adhd symptoms are recorded by using specific predetermined neurocognitive performance indicators (npi's), derived during/from the game. results of arvo are compared to the conners continuous performance test 3rd edition™ (cpt 3) that is a task-oriented, automated 14-minute computerized assessment of attention-deficit (ad) related problems in individuals aged 8 years and older. performance and safety of arvo and cpt 3 are compared in two clinical investigation populations, 8-13 years old adhd children and typically developing (td) children of the same age. test are performed by the subject while monitoring adult supervises safety of the use.


Eligibility criteria:
inclusion criteria: adhd group the inclusion criteria: 1. signed informed consent (by guardian and a child) 2. age of 8-13 at the time of consent 3. adhd set by a licensed physician 4. native language finnish / fluent finnish language td group the inclusion criteria: 1. signed informed consent (by guardian and child) 2. age of 8-13 at the time of the consent 3. native language finnish / fluent finnish language exclusion criteria: adhd group 1. any diseases of the nervous system (icd-10, g00-g99) 2. mental and behavioural disorders due to psychoactive substance use (f10-f19) 3. schizophrenia, schizotypal and delusional disorders (f20 - f29) 4. acute severe depression or mania / hypomania (f30, f32, f33) 5. phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (f40-f42) 6. severe mental retardation (f72) 7. disorders of psychological development (f80, f81, f83, f84) 8. medication taken for adhd (methylphenidate, lisdexamfetamine) on the test day (24 hour wash out) 9. atomoxetine, guanfacine 10. hearing or vision diagnosis (h90 bilateral hearing loss, h53 visual disturbances, h54 blindness and low vision) diagnosis search completeness criteria: diagnosis present/absent in patient registry kanta. td group 1. set adhd diagnosis. 2. ongoing process related to setting an adhd diagnosis, according to guardian's questionnaire. 3. any diseases of the nervous system (icd-10, g00-g99) 4. mental and behavioural disorders due to psychoactive substance use (f10-f19) 5. schizophrenia, schizotypal and delusional disorders (f20 - f29) 6. acute severe depression or mania / hypomania (f30, f32, f33) 7. phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (f40-f42) 8. severe mental retardation (f72) 9. disorders of psychological development (f80, f81, f83, f84) 10. hearing or vision diagnosis (h90 bilateral hearing loss, h53 visual disturbances, h54 blindness and low vision)

Keywords: adhd
tear film evaluation after phacoemulsification

Conditions: Cortical Senile Cataract

Summary: to compare tear film differences between surgical eyes and nonsurgical eyes in patients who had cataract surgery by phacoemulsification in one eye.

all participants granted their written informed consent to participate in the research protocol.

Eligibility criteria:
inclusion criteria: age-related cataract without surgery history and dry eye symptoms history exclusion criteria: diseases influencing tear secretion (such as sjögren syndrome, steve-johnson syndrome, diabetes, thyroid disease, etc.); history of ocular surgeries or nuclear hardness iv and v, which required the use of larger phacoemulsification energy; use of drugs that affect tear secretion and stability (such as glaucoma medications, artificial tears, corticosteroid drugs, etc.); or presence of ocular diseases (such as pterygium, blepharitis, uveitis, glaucoma, lacrimal apparatus, etc.).

Keywords: cataract ,tear film,ss-oct